Clinical study reports
Clinical study reports are the formal reports produced according to ICH guidelines following the completion of a clinical trial. They comprise detailed information on the methods, design and results of the clinical trial. Clinical study reports are used as a primary source of documentation in marketing authorisation applications submitted to health authorities.
Clinical study reports of trials investigating products in approved indications are posted on LEO Pharma corporate website after decision and accomplishment of peer-reviewed publication in scientific journals. If publication is not pursued, the clinical study report is posted within 12 months of trial completion. Posting of clinical study reports includes also clinical trials in abandoned projects (trials from 2014 and onwards).
Clinical study reports are posted on this website without appendices or patient level data. Access to patient level data from clinical trials dating back to 2000 can be requested for scientific purposes as soon as the clinical study report from that clinical trial has been posted on this site.
Summaries provide a short overview of the purpose, results, and conclusion of the clinical trial. The summary is often a section of the clinical study report. Summaries of clinical trials from 2014 and onwards are posted on LEO Pharma corporate website within 12 months of trial completion, irrespectively of approval status of the investigated compound, including abandoned projects.
For previous trials (1990 - 2013), summaries are posted for these trials investigating products in approved indications.
Protection of patient's privacy
Transparency is not an end in itself. It should not be at the expense of protecting an individual patient’s privacy. LEO Pharma, as the sponsor of a clinical trial, has made a commitment to patients to protect their privacy by safeguarding their personal data and restricting the use of data from clinical trials to respect the scope of the patients informed consent.
This commits us to redact personal information contained in clinical study reports and summaries. Furthermore, we will redact certain commercially confidential information and personal data relating to experts and staff involved in conducting the clinical trials before posting those documents on this site and making the patient level data available.
Clinical study reports and summaries
Posted clinical study reports and summaries are sorted indication wise and are available using the links below. By using the search function to the right it is furthermore possible to do a free text search in all published clinical study reports and summaries.